Comparing two sleep therapy delivery methods for people with multiple sclerosis

Trial details

Who runs it

University of Kansas Medical Center

Trial code

NCT06434571

Record updated

13 October 2026

Original description

The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 4). Reassessment of outcomes will be completed after the 6-week intervention and 6 months following completion of interventions.Read full original descriptionShow less

Comparing Telehealth-Delivered Cognitive Behavioral Therapy for Insomnia to Web-Based to Enhance Sleep, Reduce Fatigue, and Promote Neuroprotection

The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I (tCBT-I) compared to web-based CBT-I (wCBT-I) and treatment as usual (TAU) to improve sleep outcomes (Aim 1), fatigue and quality of life (Aim 2), and promote neuroprotection (Exploratory Aim 3), and to explore the characteristics of participants that predict improvement in sleep outcomes (Exploratory Aim 4). Reassessment of outcomes will be completed after the 6-week intervention and 6 months following completion of interventions.

Inclusion: 18-65 years old; Diagnosis of relapsing-remitting or secondary progressive MS based on established guidelines21 and verified by their neurologist; Mild-to-moderately severe disability (≤ 6 on Patient Determined Disability Steps (PDDS) scale); Report of difficulty falling asleep, maintaining sleep, or waking up too early at least 3 nights/week for the past 3 months with significant distress and impact on function despite adequate opportunity for sleep and not due to other sleep disorders as indicated in the DSM-5; ≥10 on Insomnia Severity Index; English speaking; ≥31 on Telephone Interview of Cognitive Status; Has a high school diploma or equivalent to serve as a proxy measurement of reading ability to ensure adequate reading ability to participate in the study; Report having access to internet service or a data plan and access to a computer, tablet, or smart phone.

Exclusion: Current or history (up to 2 years) of alcohol or drug or alcohol abuse as indicated by DSM-5 criteria; Relapse and/or corticosteroid use in the past 8 weeks; Currently receiving a behavioral sleep health intervention; Known untreated sleep disorder (such as sleep apnea or restless legs syndrome); Restless legs syndrome as determined by RLS-Diagnosis Index; Circadian rhythm sleep-wake disorder as determined by the Sleep Disorders-Revised; Parasomnia as determined by the Sleep Disorders-Revised; Score of ≥15 on the Generalized Anxiety Disorder (GAD-7) indicating severe anxiety; History of other nervous system disorder such as stroke or Parkinson's disease; Severe mental illness such as schizophrenia or bipolar disorder; History of (within 5 years) or currently conducting overnight shift work including hours of midnight-4am; >3 on STOP BANG indicating increased risk of sleep apnea; If taking benzodiazepines, non-benzodiazepines, or melatonin supplements or agonists for insomnia, taking < 3 months or dose has changed in past 3 months; Score of ≥20 on the Patient Health Questionnaire (PHQ-9) indicating severe depression or endorsement of suicidal ideation (answer 1, 2 or 3 on #9 of the PHQ-9); Currently pregnant or intending to become pregnant in the next 6 months; Severe neurological or sensory impairments that would interfere significantly with testing.

ClinicalTrials.gov NCT06434571